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2BE8J-NIO1head wearable

Mane Biotech GmbH

Application Details

Equipment Class
JAB - Part 15 Class B Digital Device
Date of Grant
Nov 26, 2025
Application Purpose
Original Equipment
Equipment Note
head wearable
Company
Mane Biotech GmbH
Country
Germany

Documents & Files

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Attestation Statements

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Cover Letter(s)

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Attestation Statements

Agent letter FCC attestation statement Kiwa RF_753, Issue 2 Page 1 of 2 15-02-2023 [PLACE ON APPLICANT/COMPANY LETTERHEAD] TO: Kiwa Nederland B.V. Wilmersdorf 50 7327 AC Apeldoorn Postbus 137 7300 AC Apeldoorn Netherlands U.S. Agent Designation for Service of Process (Applicant and U.S. Agent are Separate Parties) ATTENTION: FCC Certification – Section 2.911(d)(7) Information Designated U.S. Agent Company name: FCC US Agent, LLC FRN: 0033402884 Contact person name: Tim Payne Street address: 3722 Illinois Avenue ZIP/City/State Saint Charles, IL, 60174, USA Telephone number: 708-571-3148 Email address: [email protected] Signature: Date: This letter is to confirm that we (“the Designated U.S. Agent) have accepted the responsibility to act as the Designated U.S. Agent for Service of Process as required by section 47 CFR 2.911(d)(7) on behalf of the Applicant noted below. The Applicant acknowledges that they must maintain an agent for no less than one year after terminating all marketing and importation OR the conclusion of any Commission- related proceeding involving the equipment. The applicant further acknowledges their responsibility to inform the FCC whenever the Designated U.S. Agent information above changes. Applicant Company name: Mane Biotech GmbH Grantee Code: 2BE8J FCC ID: 2BE8J-NIO1 Contact person name: Carlos Chacón Street address: Stüttgerhofweg 1 ZIP/City/State/Country 50858, Cologne, Germany Telephone number: 004917662515766 Email address: [email protected] Signature: Date: 07.03.2024 Agent letter FCC attestation statement Kiwa RF_753, Issue 2 Page 2 of 2 15-02-2023 [PLACE ON APPLICANT/COMPANY LETTERHEAD] Revision Record Sheet: Revision Section number Page number Date Remark(s) issued by 01 07-02-2023 1 st version RvdM 02 1 15-05-2023 Added FRN to Agent details RvdM Issued/modified by : Richard van der Meer Function : Certification assessor Revision 02 Date : 15-02-2023 Verified by : Willem Jan Jong Function : Team Lead Date : 16-02-2023 Released by : Axel Gase Function : Manager Quality Assurance Date of release: : 19-02-2023

Attestation Statements

Covered list attestation FCC application letter Kiwa Page 1 of 2 RF_75 5_02 15- 02- 2023 Mane Biotech GmbH Cologne, Germany Certification Application Attestation Statements Mane Biotech GmbH Stüttgerhofweg 1 50858 Cologne Germany Subject: FCC ID: 2BE8J- NIO1 To Whom It May Concern: Statement for 47 CFR section 2.911(d)(5)(i) Mane Biotech GmbH certifies that as of the date of the application the equipment for which authorization is sought is not “covered” equipment 1 prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, including affiliates or subsidiaries of the named companies, the applicant must include an explanation on why the equipment is not “covered” equipment. Additional Explanation: <N/A> Statement for 47 CFR section 2.911(d)(5)(ii) Mane Biotech GmbH (“the applicant”) certifies that, as of the date of the filing of this application, the applicant - is / - is not (3) identified on the Covered List as an entity producing “covered” equipment. Date: 24.11.2024 City: Cologne Name (2) : Carlos Chacón Function: CEO Telephone number: 0049127662515766 Email address: [email protected] Signature: 1 - The Commission’s Covered List is published by the Public Safety and Homeland Security Bureau and posted on the Commission’s website. This Covered List, which is periodically updated, identifies particular equipment, produced by particular entities, that constitutes “covered” equipment. https://www.fcc.gov/supplychain/coveredlist . (2): For FCC it must be the Grantee Code “owner” or the authorized agent. (3): double click on the appropriate box and select ‘’checked” then “OK” Covered list attestation FCC application letter Kiwa Page 2 of 2 RF_755_02 15-02-2023 Mane Biotech GmbH Cologne, Germany Revision Record Sheet: Revision Section number Page number Date Remark(s) issued by 01 07-02-2023 1 st version RvM 02 1 15-02-2023 Changed Applicant to Company and added “Subject: FCC ID: “ RvdM Issued/modified by : Richard van de Meer Function : Certification assessor Revision : 02 Date : 15-02-2023 Verified by : Willem Jan Jong Function : Team Lead Date : 16-02-2023 Released by : Axel Gase Function : Manager Quality Assurance Date of release: : 19-02-2023

Cover Letter(s)

RF_160_05 Declaration of Authorisation Date of issue 02- 01- 2023 Declaration of Authorization We Name: Mane Biotech GmbH Address: Stüttgerhofweg 1 City: Cologne Country: Germany Declare that: Name Representative of agent: Tim Payne (1) Agent Company name: FCC US Agent, LLC Address: 3722 Illinois Avenue City: Saint Charles, IL, 60174 Country USA is authorized to apply for Certification of the following product(s): Product description: Cosmetic consumer electronic head wearable device Type designation: Consumer electronic device Trademark: niostem Validity/ expiry date on our behalf. Date: 24.11.2024 City: Cologne Name: Carlos Chacón (2) Function: CEO Signature: ............................... Notes: (1): Required for FCC application (2): For FCC it must be the Grantee Code “owner” or the authorized agent. Revision Record Sheet: Revision Section number Page number Date Remark(s) issued by 02 1 02-01-2023 History sheet added AG Issued/modified by : Axel Gase Function : Quality Manager Revision : 02 Date : 02-01-2023 Verified by : Willem Jan Jong Function : Team Lead Date : 02-01-2023 Released by : Axel Gase Function : Manager Quality Assurance Date of release: : 02-01-2023

Cover Letter(s)

FCC, Request for non-disclosure Date: 23-06-2023 RF_501, Issue 11 Page 1 of 2 Company Name: Mane Biotech Gm Address : Stüttgerhofweg 1, 50858 City: Cologne Country: Germany To: Kiwa Netherlands B.V., Dept. FCC TCB Wilmersdorf 50 7327 AC Apeldoorn The Netherlands Subject: Request for confidentiality FCC ID: 2BE8J-NIO1 Reference number: SM_P000351073 FCC Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application: Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, a pplicant hereby requests Short-Term Confidential treatment of the following materials (See notes below): Internal Photos User’s Manual Test Set-up Photos External Photos Justification: this information must not be disclosed until the product official comes to the market, which is expected in the mid term future (01.01.2028) Date: 24.11.2024 Name and signature of applicant: Carlos Chacón Notes: 1) A document or type of document can only have ONE type of confidentiality! 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)! The planned date should state in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this! 5) Request for extension or for release must be received by Kiwa NL B.V. at least 7 days before date of actual marketing or before expiration of the STC period FCC, Request for non-disclosure Date: 23-06-2023 RF_501, Issue 11 Page 2 of 2 Revision Record Sheet: Revision Section number Page number Date Remark(s) issued by 10 1 02-01-2023 History sheet added AG 11 1 & 2 23-06-2023 Corrected date and page# WJJ Issued/modified by : Willem Jan Jong Function : Team Lead Revision : 11 Date : 23-06-2023 Verified by : Axel Gase Function : Manager Quality Assurance Date : 23-06-2023 Released by : Axel Gase Function : Manager Quality Assurance Date of release: : 23-06-2023

RF Exposure Info

Kiwa Nederland B.V. FCC SAR Exclusion Report Product name : Niostem Headset Applicant : Mane Biotech GmbH FCC ID : FCC ID: 2BE8J-NIO1 IC : NA Test report No. : P000351073 003 Ver 3.0 Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 1 of 7 Laboratory information Accreditation Kiwa Nederland B.V. complies with the accreditation criteria for test laboratories as laid down in ISO/IEC 17025:2017. The accreditation covers the quality system of the laboratory as well as the specific activities as described in the authorized annex bearing the accreditation number L248 and is granted by the Dutch Council For Accreditation (RvA: Raad voor Accreditatie). Kiwa Nederland B.V. is designated by the FCC as an Accredited Test Firm for compliance testing of equipment subject to Certification under Parts 15 & 18. The Designation number is: NL0001. Kiwa Nederland B.V. is a Wireless Device Testing laboratory recognized by Innovation, Science and Economic Development Canada to test to Canadian radio equipment requirements. The Industry Canada company number for Kiwa Nederland B.V. is: 4173A. The CABID is NL0001. Kiwa Nederland B.V. is a registered Conformity Assessment body (CAB) under the Japan-EC MRA (Agreement on Mutual Recognition between Japan and the European Community). The registration number is: 201. Documentation The test report must always be reproduced in full; reproduction of an excerpt only is subject to written approval of the testing laboratory. The documentation of the testing performed on the tested devices is archived for 10 years at Kiwa Nederland B.V. Testing Location Test Site Kiwa Nederland B.V. Test Site location Wilmersdorf 50 7327 AC Apeldoorn The Netherlands Tel. +31 88998 3393 Test Site FCC NL0001 CABID NL0001 Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 2 of 7 Revision History Version Date Remarks By v0.50 20-03-2025 First draft MHK v1.00 11-04-2025 Final release MHK V2.0 27-05-2025 Customer feedback MHK V3.0 11-06-2025 Customer feedback MHK Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 3 of 7 Table of Contents Revision History ............................................................................................................................................... 2 1 General Description ................................................................................................................................. 4 1.1 Applicant ............................................................................................................................................... 4 1.2 Manufacturer ........................................................................................................................................ 4 1.3 Tested Equipment Under Test (EUT) ..................................................................................................... 4 1.4 Applicable standards ............................................................................................................................. 5 1.5 Conclusions ........................................................................................................................................... 6 2 SAR exclusion Evaluation ......................................................................................................................... 7 2.1 Transmitter specifications ..................................................................................................................... 7 2.2 Evaluation calculations .......................................................................................................................... 7 2.3 Conclusion ............................................................................................................................................. 7 Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 4 of 7 1 General Description 1.1 Applicant Client name: Mane Biotech GmbH Address: Stüttgerhofweg 1 Zip code: 50858 Country: Germany Telephone: 17662515766 E-mail: [email protected] Contact name: Carlos Chacón 1.2 Manufacturer Manufacturer name: Mane Biotech GmbH Address: Stüttgerhofweg 1 Zip code: 50858 Country: Germany Telephone: 17662515766 E-mail: [email protected] Contact name: Carlos Chacón 1.3 Tested Equipment Under Test (EUT) Product name: Niostem headset Brand name: Niostem FCC ID: FCC ID: 2BE8J-NIO1 IC: NA Product description: Device is a wearable headset that stimulates scalp. Variant model(s): -- Batch and/or serial No. V1.0 Software version: V1.0 Hardware version: V1.0 Date of receipt: 10-12-2024 Tests started: 02-01-2025 Testing ended: 18-02-2025 Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 5 of 7 1.4 Applicable standards 47 CFR § 1.1307 (b)(1)(i)(A) Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 6 of 7 1.5 Conclusions The sample of the product showed NO NON-COMPLIANCES to the specifications stated in paragraph 1.4 of this report. The results of the test as stated in this report, are exclusively applicable to the product items as identified in this report. Kiwa Netherland B.V. accepts no responsibility for any properties of product items in this test report, which are not supported by the tests as specified in paragraph 1.4 “Applicable standards”. Assessment is performed by: Name : ing, Maaz. H. Khan Review of assessment methods and report by: Name : P. van Wanrooij, BASc The above conclusions have been verified by the following signatory: Date : 12-06-2025 Name : P. van Wanrooij Function : Test Engineer Signature : Report number: P000351073 003 Ver 3.0 Kiwa Nederland B.V. Page 7 of 7 2 SAR exclusion Evaluation 2.1 Transmitter specifications Transmitter 1 Variable (unit) Value Symbol Conducted time-averaged output power (mW) 0.000127 P Time-averaged output power ERP (mW) 0.0002 P ERP Operating frequency range (MHz) 2480 f Separation distance (cm) 2 d Separation distance (m) 0.02 R 2.2 Evaluation calculations Transmitter 1 Transmitter 1 is evaluated…

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Test Report

Kiwa Nederland B.V. Test report for 15.247 (DSS), 15.209 and 15.207 The RvA is signatory to ILAC - MRA Product name : Niostem headset Applicant : Mane Biotech GmbH FCC ID : FCC ID: 2BE8J-NIO1 IC : NA Test report No. : P000351073 001 Ver 3.0 Report number: P000351073 001 Ver 3.0 Kiwa Nederland B.V. Page 1 of 33 Laboratory information Accreditation Kiwa Nederland B.V. complies with the accreditation criteria for test laboratories as laid down in ISO/IEC 17025:2017. The accreditation covers the quality system of the laboratory as well as the specific activities as described in the authorized annex bearing the accreditation number L248 and is granted by the Dutch Council For Accreditation (RvA: Raad voor Accreditatie). Kiwa Nederland B.V. is designated by the FCC as an Accredited Test Firm for compliance testing of equipment subject to Certification under Parts 15 & 18. The Designation number is: NL0001. Kiwa Nederland B.V. is a Wireless Device Testing laboratory recognized by Innovation, Science and Economic Development Canada to test to Canadian radio equipment requirements. The Industry Canada company number for Kiwa Nederland B.V. is: 4173A. The CABID is NL0001. Kiwa Nederland B.V. is a registered Conformity Assessment body (CAB) under the Japan-EC MRA (Agreement on Mutual Recognition between Japan and the European Community). The registration number is: 201. Documentation The test report must always be reproduced in full; reproduction of an excerpt only is subject to written approval of the testing laboratory. The documentation of the testing performed on the tested devices is archived for 10 years at Kiwa Nederland B.V. Testing Location Test Site Kiwa Nederland B.V. Test Site location Wilmersdorf 50 7327 AC Apeldoorn The Netherlands Tel. +31 88998 3393 Test Site FCC NL0001 CABID NL0001 Report number: P000351073 001 Ver 3.0 Kiwa Nederland B.V. Page 2 of 33 Revision History Version Date Remarks By v0.5 27-03-2025 First draft MHK v1.0 24-04-2025 Initial release MHK V2.0 27-05-2025 Customer feedback MHK V3.0 27-05-2025 Customer feedback MHK Report number: P000351073 001 Ver 3.0 Kiwa Nederland B.V. Page 3 of 33 Table of Contents Revision History ............................................................................................................................................... 2 Summary of Test results .................................................................................................................................. 5 1 General Description ................................................................................................................................. 6 1.1 Applicant ............................................................................................................................................... 6 1.2 Manufacturer ........................................................................................................................................ 6 1.3 Tested Equipment Under Test (EUT) ..................................................................................................... 6 1.3.1 Auxiliary items .................................................................................................................................. 7 1.4 Product specifications of Equipment under test ................................................................................... 8 1.5 Environmental conditions ..................................................................................................................... 8 1.6 Measurement standards ....................................................................................................................... 8 1.7 Applicable standards ............................................................................................................................. 8 1.8 Observation and remarks ...................................................................................................................... 8 1.9 Modifications to the EUT (Equipment Under Test) ............................................................................... 8 1.10 Conclusions ........................................................................................................................................... 9 2 Test configuration of the Equipment Under Test .................................................................................... 10 2.1 Test mode ........................................................................................................................................... 10 2.2 Test setups .......................................................................................................................................... 10 2.3 Equipment used in the test configuration .......................................................................................... 13 2.4 Sample calculations ............................................................................................................................. 13 3 Test results ............................................................................................................................................. 14 3.1 Radiated spurious emissions ............................................................................................................... 14 3.1.1 Limit ................................................................................................................................................ 14 3.1.2 Measurement instruments ............................................................................................................. 14 3.1.3 Test setup ....................................................................................................................................... 14 3.1.4 Test procedure ................................................................................................................................ 15 3.1.5 Measurement Uncertainty ...........................…

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Test Report

Kiwa Nederland B.V. Test report for 47 CFR Part 15 Subpart B The RvA is signatory to ILAC - MRA Product name : Niostem headset Applicant : Mane Biotech GmbH FCC ID : FCC ID: 2BE8J-NIO1 IC : NA Test report No. : P000351073 002 Ver 3.0 Report number: P000351073 002 Ver 3.0 Kiwa Nederland B.V. Page 1 of 25 Laboratory information Accreditation Kiwa Nederland B.V. complies with the accreditation criteria for test laboratories as laid down in ISO/IEC 17025:2017. The accreditation covers the quality system of the laboratory as well as the specific activities as described in the authorized annex bearing the accreditation number L248 and is granted by the Dutch Council For Accreditation (RvA: Raad voor Accreditatie). Kiwa Nederland B.V. is designated by the FCC as an Accredited Test Firm for compliance testing of equipment subject to Certification under Parts 15 & 18. The Designation number is: NL0001. Kiwa Nederland B.V. is a Wireless Device Testing laboratory recognized by Innovation, Science and Economic Development Canada to test to Canadian radio equipment requirements. The Industry Canada company number for Kiwa Nederland B.V. is: 4173A. The CABID is NL0001. Kiwa Nederland B.V. is a registered Conformity Assessment body (CAB) under the Japan-EC MRA (Agreement on Mutual Recognition between Japan and the European Community). The registration number is: 201. Documentation The test report must always be reproduced in full; reproduction of an excerpt only is subject to written approval of the testing laboratory. The documentation of the testing performed on the tested devices is archived for 10 years at Kiwa Nederland B.V. Testing Location Test Site Kiwa Nederland B.V. Test Site location Wilmersdorf 50 7327 AC Apeldoorn The Netherlands Tel. +31 88998 3393 Test Site FCC NL0001 CABID NL0001 Report number: P000351073 002 Ver 3.0 Kiwa Nederland B.V. Page 2 of 25 Revision History Version Date Remarks By v0.50 20-03-2025 First draft MHK v1.00 11-04-2025 Final release MHK V2.0 27-05-2025 Customer feedback MHK V3.0 11-06-2025 Customer Feedback MHK Report number: P000351073 002 Ver 3.0 Kiwa Nederland B.V. Page 3 of 25 Table of Contents Revision History ............................................................................................................................................... 2 Summary of Test results .................................................................................................................................. 5 1 General Description ................................................................................................................................. 6 1.1 Applicant ............................................................................................................................................... 6 1.2 Manufacturer ........................................................................................................................................ 6 1.3 Tested Equipment Under Test (EUT) ..................................................................................................... 6 1.4 Product specifications of Equipment under test ................................................................................... 8 1.5 Environmental conditions ..................................................................................................................... 8 1.6 Measurement standards ....................................................................................................................... 8 1.7 Applicable standards ............................................................................................................................. 8 1.8 Observation and remarks ...................................................................................................................... 8 1.9 Conclusions ........................................................................................................................................... 9 2 Test configuration of the Equipment Under Test .................................................................................... 10 2.1 Test mode ........................................................................................................................................... 10 2.2 Test setups .......................................................................................................................................... 10 2.2.1 Radiated emissions test setup 30 MHz - 1 GHz .............................................................................. 10 2.2.2 Radiated emissions test setup above 1 GHz ................................................................................... 10 2.2.3 AC Power line conducted emissions test setup .............................................................................. 11 2.3 Test methodology. .............................................................................................................................. 11 2.4 Equipment modifications. ................................................................................................................... 11 2.5 Equipment used in the test configuration .......................................................................................... 12 2.6 Sample calculations ............................................................................................................................. 12 3 Test results ............................................................................................................................................. 13 3.1 Radiated spurious emissions ............................................................................................................... 13 3.1.1 Limit ................................................................................................................................................ 13 3.1.2 Measurement instruments ...........................................................................…

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Contact Information

Applicant

Carlos Chacon
[email protected]Fax: --

Technical Contact

Mane Biotech GmbHCarlos Chacon
[email protected]

Stuttgerhofweg 1 · Germany

Test Firm

Kiwa Nederland B.V.Willem Jong
[email protected]

Technical Specifications

#Rule PartsFrequency RangePower Output
115B--
Confidentiality
Long Term
Grant Notes
Device contains a pre-certified module FCC ID: YCP-STM32WB5M001.